CIS
5 FDA 510(k) clearances · Product code
41 daysmedian time to decision
109 days90th percentile
5clearances measured
FDA profile
- Official device name
- Hydrazone Colorimetry, Ast/Sgot
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1100
- Medical specialty
- Clinical Chemistry
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST) (K032027) | Cholestech Corp. | 2003-09-05 |
| COBAS READY AST REAGENT (K896238) | Roche Diagnostic Systems, Inc. | 1990-02-16 |
| IN-VITRO TEST DETERMINATION OF SGOT (AST) (K854187) | Clinical Data, Inc. | 1985-11-25 |
| OPTIONAL TOTAL CA-MODULE FOR IL 504/508 (K812872) | Instrumentation Laboratory CO | 1981-10-26 |
| ELVI SGOT & SGPT TRANSAMINASE (K792410) | Volu Sol Medical Industries | 1979-12-06 |
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Every clearance here is in the API, with alerts when new ones post.